Human Papillomavirus Infections
Conditions
Brief summary
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.
Detailed description
This study is part of a vaccine program which aims to generate a therapeutic vaccine for women with HPV types 16 or 18 infection, with a focus on early disease interception. The study consists of 3 periods: Screening period of up to 42 days (6 weeks), followed by prime and boost immunizations and follow-up visits up to 12 months after the first vaccination. Evaluation of the safety/reactogenicity of the vaccine regimens will include physical assessment by study-site personnel, participant reports on signs and symptoms and laboratory assessments following vaccinations. Immunogenicity and Virology/Histology assessments will also be performed.
Interventions
BIOLOGICALAd26.HPV16
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
BIOLOGICALAd26.HPV18
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
BIOLOGICALMVA.HPV16/18
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
BIOLOGICALPlacebo
Participants will receive matched placebo as a solution for intramuscular injection.
Sponsors
Bavarian Nordic
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol * Must have an human papillomavirus (HPV) type 16 or 18 infection of the cervix as determined by a qualitative PCR test within 8 weeks prior to screening or at the time of screening. Available history of high-risk (HR)-HPV positivity and HPV16 or HPV18 positivity positivity will be recorded * Must have a recent colposcopy result (with a maximum of 12 months old at screening); in case a colposcopy has not been performed before, it will be done as screening procedure * Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies * Agrees not to donate blood until 3 months after receiving the last dose of study vaccine
Exclusion criteria
* In case cytology results are available, participant has current or history of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS) or any high-grade vulvar, vaginal or anal intraepithelial neoplasia * Current or history of cervical intraepithelial neoplasia (CIN)2+ or cervical cancer * Confirmed co-infection with both HPV16 and HPV18 * History of an underlying clinically significant acute or chronic medical condition, other than infection with HPV, or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Tests positive for human immunodeficiency virus (HIV) at screening * Chronic active hepatitis B or hepatitis C infection, verified at screening by hepatitis B surface antigen or anti-hepatitis C virus antibody, respectively * Vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators * Exposed to at least 1 dose of an HPV prophylactic vaccine or participant has participated in the past in another preventive or therapeutic HPV vaccine study * Clinically significant gynecological abnormalities that could, in the judgment of the investigator, interfere with study evaluation (for example \[e.g.\], prolapse, myoma, fibroid, hysterectomy) * Symptomatic vaginal or genital infection (including genital herpes) as confirmed by physician or investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) | Up to 7 days after each vaccination (Up to Day 64) | Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling. |
| Number of Participants With Solicited Systemic AEs | Up to 7 days after each vaccination (Up to Day 64) | Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever. |
| Number of Participants With Unsolicited AEs | 28 days after each vaccination (Up to Day 85) | Number of participants with unsolicited AEs were reported. Unsolicited AEs included all AEs for which the participant was not specifically questioned in the participant diary. |
| Number of Participants With Serious Adverse Events (SAEs) | Up to 12 months after the first vaccination (target visit Day 366) | Number of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 57, Day 78, Day 239, and Day 366 | Percentage of participants with HPV-Specific CD8+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). |
| Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 57, Day 78, Day 239, and Day 366 | Percentage of participants with HPV-Specific CD4+ T-cell responses for IFNg+ to peptide pools were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). |
| Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 57, Day 78, Day 239, and Day 366 | Percentage of participants with HPV-Specific CD8+ T-cell responses for TNFa+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). |
| Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 57, Day 78, Day 239, and Day 366 | Percentage of participants with HPV-Specific CD4+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). |
| Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 57, Day 78, Day 239, and Day 366 | Percentage of participants with HPV-Specific CD4+ T-cell responses for TNF a+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). |
| Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 57, Day 78, Day 239, and Day 366 | Percentage of participants with HPV-Specific CD8+ T-cell responses for IFNg+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). |
Countries
Belgium, United States
Participant flow
Pre-assignment details
Due to premature study termination, participants were only randomized and treated for Regimen 1 and Placebo. Hence, all results are reported below for Regimen 1 and Placebo only and not for Regimen 2 and 3.
Participants by arm
| Arm | Count |
|---|---|
| Regimen 1 Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5\*10\^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2\*10\^8 infectious units (Inf.U) on Day 57. | 5 |
| Placebo Participants received matching placebo on Day 1 and Day 57. | 4 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 0 | 1 |
| Overall Study | Study terminated by sponsor | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Regimen 1 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 11.85 | 43.6 years STANDARD_DEVIATION 9.26 | 45.5 years STANDARD_DEVIATION 5.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment UNITED STATES | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 2 / 5 | 1 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 12 months after the first vaccination (target visit Day 366)
Population: FAS included all participants with at least one vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Regimen 1 | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Placebo | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants With Solicited Local Adverse Events (AEs)
Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.
Time frame: Up to 7 days after each vaccination (Up to Day 64)
Population: Full analysis set (FAS) included all participants with at least one vaccination. Here, n (number analyzed) is defined as participants analyzed for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Regimen 1 | Number of Participants With Solicited Local Adverse Events (AEs) | Post- Dose 1 | 2 Participants |
| Regimen 1 | Number of Participants With Solicited Local Adverse Events (AEs) | Post- Dose 2 | 1 Participants |
| Placebo | Number of Participants With Solicited Local Adverse Events (AEs) | Post- Dose 1 | 0 Participants |
| Placebo | Number of Participants With Solicited Local Adverse Events (AEs) | Post- Dose 2 | 0 Participants |
Primary
Number of Participants With Solicited Systemic AEs
Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever.
Time frame: Up to 7 days after each vaccination (Up to Day 64)
Population: FAS included all participants with at least one vaccination. Here, n (number analyzed) is defined as participants analyzed for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Regimen 1 | Number of Participants With Solicited Systemic AEs | Post-Dose 1 | 4 Participants |
| Regimen 1 | Number of Participants With Solicited Systemic AEs | Post-Dose 2 | 1 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs | Post-Dose 1 | 0 Participants |
| Placebo | Number of Participants With Solicited Systemic AEs | Post-Dose 2 | 0 Participants |
Primary
Number of Participants With Unsolicited AEs
Number of participants with unsolicited AEs were reported. Unsolicited AEs included all AEs for which the participant was not specifically questioned in the participant diary.
Time frame: 28 days after each vaccination (Up to Day 85)
Population: FAS included all participants with at least one vaccination. Here, n (number analyzed) is defined as participants analyzed for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Regimen 1 | Number of Participants With Unsolicited AEs | Post-Dose 2 | 0 Participants |
| Regimen 1 | Number of Participants With Unsolicited AEs | Post-Dose 1 | 2 Participants |
| Placebo | Number of Participants With Unsolicited AEs | Post-Dose 1 | 1 Participants |
| Placebo | Number of Participants With Unsolicited AEs | Post-Dose 2 | 0 Participants |
Secondary
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+
Percentage of participants with HPV-Specific CD4+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Time frame: Day 57, Day 78, Day 239, and Day 366
Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, n (number analyzed) is defined as participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 57: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 78: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 239: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 366: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 57: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 78: E6/E7 | 33.3 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 239: E6/E7 | 33.3 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 336: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 78: Combined Peptide Pools | 33.3 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 239: Combined Peptide Pools | 33.3 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 239: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 57: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 239: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 78: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 78: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 239: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 336: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 366: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 57: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Day 78: E6/E7 | 0 Percentage of participants |
Secondary
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+
Percentage of participants with HPV-Specific CD4+ T-cell responses for TNF a+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Time frame: Day 57, Day 78, Day 239, and Day 366
Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, n (number analyzed) is defined as participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 57: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 78: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 239: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 366: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 57: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 78: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 239: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 366: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 78: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 239: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 239: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 57: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 239: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 78: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 78: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 239: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 366: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 366: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 57: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Day 78: E6/E7 | 0 Percentage of participants |
Secondary
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+
Percentage of participants with HPV-Specific CD8+ T-cell responses for IFNg+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Time frame: Day 57, Day 78, Day 239, and Day 366
Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, n (number analyzed) is defined as participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 57: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 78: E2 | 100 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 239: E2 | 66.7 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 366: E2 | 50 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 57: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 78: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 239: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 366: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 78: Combined Peptide Pools | 100 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 239: Combined Peptide Pools | 66.7 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 366: Combined Peptide Pools | 50 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 239: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 57: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 239: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 78: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 78: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 239: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 366: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 366: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 57: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Day 78: E6/E7 | 0 Percentage of participants |
Secondary
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+
Percentage of participants with HPV-Specific CD8+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Time frame: Day 57, Day 78, Day 239, and Day 366
Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, n (number analyzed) is defined as participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 57: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 78: E2 | 66.7 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 239: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 366: E2 | 50 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 57: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 78: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 239: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 366: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 78: Combined Peptide Pools | 66.7 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 239: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 366: Combined Peptide Pools | 50 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 239: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 57: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 239: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 78: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 78: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 239: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 366: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 366: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 57: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Day 78: E6/E7 | 0 Percentage of participants |
Secondary
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+
Percentage of participants with HPV-Specific CD8+ T-cell responses for TNFa+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Time frame: Day 57, Day 78, Day 239, and Day 366
Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, n (number analyzed) is defined as participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 57: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 78: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 239: E2 | 33.3 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 366: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 57: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 78: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 239: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 366: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 78: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 239: Combined Peptide Pools | 33.3 Percentage of participants |
| Regimen 1 | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 239: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 57: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 239: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 78: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 78: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 239: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 366: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 366: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 57: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Day 78: E6/E7 | 0 Percentage of participants |
Secondary
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+
Percentage of participants with HPV-Specific CD4+ T-cell responses for IFNg+ to peptide pools were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Time frame: Day 57, Day 78, Day 239, and Day 366
Population: FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, n (number analyzed) is defined as participants analyzed for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 57: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 78: E2 | 33.3 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 239: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 366: E2 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 57: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 78: E6/E7 | 33.3 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 239: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 366: E6/E7 | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 78: Combined Peptide Pools | 33.3 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 239: Combined Peptide Pools | 0 Percentage of participants |
| Regimen 1 | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 239: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 57: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 239: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 78: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 78: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 239: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 366: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 366: E2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 366: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 57: E6/E7 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 57: Combined Peptide Pools | 0 Percentage of participants |
| Placebo | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Day 78: E6/E7 | 0 Percentage of participants |